PSTB100 Study in Healthy Adult Subjects

NCT07702279 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PSTB100-01-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled, dose-escalation， first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of PSTB100 tablets.

Conditions

Healthy Adult Subjects

Keywords

Phase I; PSTB100; healthy adult subjects

Outcome Measures

Primary Outcomes (14)

• Time to Reach Maximum Observed Plasma concentration (Tmax)

  PK characteristics after single dose

  Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

• Maximum Observed PSTB100 Plasma Concentration (Cmax)

  PK characteristics after single dose

  Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

• PSTB100 area under the plasma concentration-time curve (AUC0-24h, AUC0-t, AUC0-∞, etc.)

  PK characteristics after single dose

  Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

• Plasma clearance (CL/F)

  PK characteristics after single dose

  Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

• Plasma elimination half-life (T₁/₂)

  PK characteristics after single dose

  Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

• Mean residence time (MRT)

  PK characteristics after single dose

  Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose

• Steady-state time to peak (Tmax,ss)

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Steady-state peak concentration (Cmax,ss)

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Steady-state trough concentration (Cmin,ss)

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Average steady-state plasma concentration (Cav,ss)

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Area under the steady-state plasma concentration-time curve (AUCss)

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Fluctuation factor (DF) between trough and peak concentrations;

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Accumulation ratios Rac:Cmax

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

• Accumulation ratios Rac:AUC.

  PK characteristics after multiple dose

  Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.

Secondary Outcomes (3)

• Plasma Metabolite Identification

  Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose

• Inflammatory Cytokine Markers

  Pre-dose PD blood sample (before first dose): to be collected within 1 hour pre-dose Pre-dose PD blood sample (before subsequent doses): to be collected within 15 minutes pre-dose

• Cerebrospinal fluid (CSF)

  1 hours post-Day 7 dose, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post Day 7 dose

Study Arms (2)

A SAD study includes 5 predefined cohorts: Cohorts 1-5 (0.25 mg, 1 mg, 3 mg, 10 mg, 20 mg).

EXPERIMENTAL

The Single Ascending Dose (SAD) study uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single oral dose of PSTB100 Tablets in healthy adult subjects under fasting conditions.

Drug: PSTB100 tablets

A MAD study with randomized, double-blind, placebo-controlled

EXPERIMENTAL

The MAD study includes 3 predefined dose cohorts (Cohorts 6-8): 2 mg once daily 5 mg once daily 10 mg once daily All cohorts receive 7 consecutive days of dosing. Cohorts 6, 7: 8 subjects each (6 active, 2 placebo) Cohort 8: 14 subjects (12 active, 2 placebo)

Drug: PSTB100 tablets

Interventions

PSTB100 tablets DRUG

PSTB100 tablets: 0.25 mg, 1 mg, 3 mg, 10 mg, 20 mg.

A SAD study includes 5 predefined cohorts: Cohorts 1-5 (0.25 mg, 1 mg, 3 mg, 10 mg, 20 mg).

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects aged 18-55 years (inclusive) at screening, with no gender restriction.
• Cohort 8 will enroll only male subjects aged 18-45 years (inclusive) at screening.
• Body Mass Index (BMI) of 18.0 to 32.0 kg/m² (inclusive), and 19.0 to 26.0 kg/m² (inclusive) for Cohort 8.
• Good health status confirmed by medical history, vital signs, physical examination, 12-lead ECG, laboratory tests (blood routine, biochemistry, coagulation function, urinalysis), etc., with no clinically significant abnormalities.
• Fully informed about the study, voluntary participation, and signed Informed Consent Form (ICF).
• Women of childbearing potential who have no pregnancy plan from the screening period until 1 month after the end of the trial, and agree to use contraceptive methods as detailed further in the protocol (see Appendix 3) from signing the ICF until 30 days after last dose.
• Males who agree to use contraception as detailed further in the protocol (see Appendix 3) with partners of childbearing potential from signing ICF until 90 days after last dose.

You may not qualify if:

• Females who are pregnant (positive or clinically abnormal pregnancy test result), lactating, or planning to become pregnant.
• Pulse rate ≤50 beats/min or \>100 beats/min at screening.
• Systolic blood pressure \<90 mmHg or ≥140 mmHg, or diastolic blood pressure \<60 mmHg or ≥90 mmHg at screening.
• History or current presence of clinically significant diseases or abnormalities in cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, dermatological, ophthalmological, infectious, or psychiatric systems, including but not limited to history of childhood asthma; history of eczema, no use of steroid creams for 3 months prior to screening; history fully resolved gestational diabetes; current or history of attention deficit hyperactivity disorder (ADHD), anxiety or depression (no use of antidepressants for at least 6 months prior to screening); Gilberts syndrome.
• Subjects with previous non-severe diseases or cured acute diseases may be enrolled if the assessor confirms no impact on the clinical trial.
• Use of tobacco, coffee, St. John's wort, grapefruit, grapefruit juice, cranberry juice, or strenuous exercise within 24 hours before enrollment.
• Suspected or confirmed allergy to any ingredient of the investigational product, or any known allergy history.
• Previous surgery that may affect the clinical trial results (including but not limited to cholecystectomy, subtotal gastrectomy; excluding minor surgeries such as subcutaneous lipoma resection).
• Use of any medication within 14 days before the study drug administration, including over-the-counter drugs and herbal medicines (except vitamins and calcium tablets), or dietary supplement within 7 days before the study drug administration.
• Blood loss or blood donation exceeding 400 mL within 30 days before screening (physiological blood loss excluded).
• Participation in any clinical trial of investigational drugs or medical devices within 3 months before screening (excluding subjects who failed screening).
• History of alcohol abuse. Subjects who consumed more than 14 standard alcohol units weekly within the past year (1 standard unit ≈ 250 mL of 5% beer; 100 mL of 12.5% wine; 30 mL of 42% spirits) or who refuse to abstain from alcohol during the trial.
• History of smoking abuse (average ≥ 5 cigarettes daily within 1 month before screening) or refusal to abstain from smoking during the trial.
• History of drug abuse or positive urine drug screening result during screening (subjects with positive cotinine at screening \[D-28\~D-2\] will be not excluded if a negative cotinine is obtained on D-1).
• Breath alcohol test with positive result at screening.

Sponsors & Collaborators

• Prospect Therapeutics (Nanjing) Limited: lead

Study Sites (1)

Nucleus Network Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 14, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): June 12, 2027
• Study Completion (Estimated): September 6, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

AU (1)